During the period equipment is being purchased and put into operation, multiple processes are essential for a smooth and timely integration of the equipment in the routine production process. Additionally, all these stages must be documented for written proof and review by the regulatory body at later stages.
These steps are essential due to reasons such as fulfilling the buyer's requirements and realistic machine design. It becomes more relevant for the pharmaceutical industry due to the product's criticality and regulatory body regulations.
The pharma equipment life cycle is part of a more extensive process, where every aspect, such as environment, company's footprint, and market forecast of equipment, is studied for compatibility and acceptability.
However, this article will only focus on steps that a pharmaceutical manufacturer must follow, from purchasing equipment to putting it into production, assuming all other factors have been considered and management has decided to procure new equipment..
Life cycle
Let's discuss some common stages of a purchasing equipment in pharmaceutical industry
User requirement specifications
User Requirement Specification - URS is the first stage in the equipment procurement process and acts as a benchmark for the machine manufacturer and all the later-stage activities.
URS contains all requirements for pharma manufacturers and expectations that a machine buyer has from that particular equipment. Commonly, a URS includes two types of information: technical and commercial.
The technical part consists of all the technical details such as electrical, mechanical, and instrumentation because these details affect the machine working and directly impact the output product.
In the commercial section, all the financial details are added—for example, the procedure of opening LC and releasing payment.
The URS is created by a team comprising all relevant stakeholders, such as the Quality, Production (User), and Engineering departments.
The engineering department is responsible for verifying the URS according to the engineering specifications, such as spare parts availability, design, available services, and maintenance. Additionally, it is also responsible for verifying the overall performance and working.
The production department is responsible for ensuring all production requirements have been fully defined and included. Production is responsible for concentrating on a market forecast, existing inventory, and existing facilities.
The quality department ensures that all processes and operations follow acceptable design and meet regulatory regulations. It also focuses on the rule of a target market. For example, if an African country plans to market its product in China, it must concentrate on Chinese regulations.
After the URS is finalized, it is sent to all stakeholders for feedback and review. If there is any feedback, it is again reviewed, and URS is updated. After the final evaluation, the URS is finalized and signed by all the contributing members, and the final authority from the management. The URS is sent to the Pharma machine manufacturer at this stage for their review and feedback.
The feedback from the machine manufacturer is reviewed, and if necessary, further correspondence is made. This continues until the machine manufacturer and buyer agree on the machine specification. When both parties agree on the URS, it is vetted and becomes part of the agreement.
After mutual approval from the machine buyer and manufacturer, the buyer informs the manufacturer to start machine manufacturing within the given timeline.
The manufacturer informs the buyer about machine’s current and final status.
The manufacturer continuously updates the buyer about the machine's status and informs the buyer if any discrepancy occurs during manufac...
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